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NCT06041516 · ClinicalTrials.gov registry record · Phase 1
A First-in-Human Phase I Trial With Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors, Carcinomas and Malignant Peripheral Nerve Sheath Tumors
A Phase 1 study of Neuroendocrine Tumors and Carcinoma, Neuroendocrine, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT06041516: Recruiting Phase 1 study of Neuroendocrine Tumors and Carcinoma, Neuroendocrine, sponsored by National Cancer Institute (NCI).
NCT06041516 is a Phase 1 study of Neuroendocrine Tumors and Carcinoma, Neuroendocrine that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 70 participants, below the 178-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06041516, a Phase 1 study of Neuroendocrine Tumors and Carcinoma, Neuroendocrine, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Neuroendocrine neoplasms (NENs) are rare cancers in the gastrointestinal tract, pancreas, lungs, adrenal glands, and other areas of the body. Many of these cancers have a high risk of relapse and a low chance of survival. Better treatments are needed. Objective: To test a new drug, ADCT-701, in people with NENs. Eligibility: Adults aged 18 and older with NENs. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and tests of heart functioning. Their ability to perform normal daily activities will be tested. A biopsy may be needed: A sample of tissue will be removed from the tumor. ADCT-701 is given through a tube attached to a needle inserted into a vein in the arm. Participants will receive the drug treatment on the first day of 21-day treatment cycles. They will visit the clinic a total of 10 times during the first two cycles. After that, they will visit the clinic 2 times during each cycle. Imaging scans, blood draws, heart function tests, and other tests will be repeated during study visits. Each visit will last up to 8 hours. Participants may continue receiving treatment with the study drug for up to 2 years. After treatment ends, participants will have follow-up clinic visits 4 times in 4 months. They will have a physical exam, with heart and blood tests, at each visit. After that, they will have follow-up clinic visits every 9 weeks; these visits will include imaging scans. Follow-up visits will continue for up to 5 years after treatment began....
Primary Outcome
Number of dose-limiting toxicities (DLTs) by assessing adverse events (AE) by type and grade of toxicity.
Conditions Studied
Interventions
- DRUG ADCT-701
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2024-06-17 |
| Est. Completion | 2029-10-30 |
| Phase | Phase 1 |
What NCT06041516 shows while recruiting
NCT06041516 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 178-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (61% lower).
The record links to 5 conditions, with Neuroendocrine Tumors appearing as the primary indexed condition, and to 1 intervention - of which ADCT-701 is the first listed.
NCT06041516 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06041516 about?
NCT06041516 is a clinical study titled "A First-in-Human Phase I Trial With Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors, Carcinomas and Malignant Peripheral Nerve Sheath Tumors". Background: Neuroendocrine neoplasms (NENs) are rare cancers in the gastrointestinal tract, pancreas, lungs, adrenal glands, and other areas of the body. Many of these cancers have a high risk of relapse and a low chance of survival. Better treatments are needed. Objective: To test a new drug, AD...
What is the current status of trial NCT06041516?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2024-06-17. Estimated completion is 2029-10-30.
What conditions does trial NCT06041516 study?
This clinical trial studies the following conditions: Neuroendocrine Tumors, Carcinoma, Neuroendocrine, Neuroendocrine Carcinomas, Carcinoma, Adrenocortical, Carcinoma, Adrenal Cortical.
What interventions are being tested in trial NCT06041516?
The interventions under investigation include: ADCT-701 (DRUG).
Who is sponsoring clinical trial NCT06041516?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06041516 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06041516's enrollment target sits among peer trials
70 24th of 52 higher than 28 of 52 other Neuroendocrine Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroendocrine Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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